Comparing PET-CT Using C-11 Choline and 18F-Fluoromethylcholine in Patients With Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title: A Cancer Research UK Phase II Trial to Compare [11C]Choline and [18F]Choline Each Given as a Single Administration Via Intravenous Injection for Imaging Patients With Metastatic Prostate Cancer

Status Withdrawn

Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) and computed tomography (CT) imaging, may help find and diagnose metastatic prostate cancer.

PURPOSE: This phase II trial is studying the side effects of C-11 choline and 18F-fluoromethylcholine and to see how well they work when used in PET and CT imaging in patients with metastatic prostate cancer.

Clinical Trial Description

OBJECTIVES:

• To compare C-11 choline to 18F-fluoromethylcholine using positron emission tomography and computed tomography imaging in their ability to detect metastatic prostate cancer.

• To compare the best early-phase (immediate) scanning of the two agents against the late-phase (one-hour delayed) 18F-fluoromethylcholine scanning in their ability to detect metastatic prostate cancer.

• To assess the safety of C-11 choline and 18F-fluoromethylcholine in these patients.

OUTLINE: Patients receive C-11 choline IV followed by a 10-minute dynamic positron emission tomography (PET) scan over the pelvis and then 5-minute scans at each bed position, from the pelvis to the base of the skull, (up to a maximum of 7 additional bed positions) lasting up to 45 minutes on day 1. Beginning 3 hours later, patients receive 18F-fluoromethylcholine IV followed by the same scanning protocol above lasting approximately 45 minutes. An additional 1-hour delayed PET-computed tomography (CT) scanning is then performed, which involves a 5-minute scan at each bed position from the pelvis to the base of the skull (up to a maximum of 7 bed positions) with 18F-fluoromethylcholine, lasting approximately 35 minutes. Patients then undergo treatment as per the normal standard of care following participation in this trial.

After completion of study treatment, patients are followed between 3-7 days.

Peer Reviewed and Funded or Endorsed by Cancer Research UK ;

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

• NCT number: NCT01132599
• Study type: Interventional
• Source: Cancer Research UK
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 2010